Monday, March 19, 2001
Designing trials is challenging enough, but training investigators and
managing hospitals to properly conduct the studies adds another level of difficulty.
Intrabiotics Pharmaceuticals Inc. learned that the hard way, resulting in at least a
one-year delay in completion of its Phase III trial of Ramoplanin Oral for the prevention
of vancomycin-resistant enterococci (VRE) infections in patients who are immunocompromised
due to chemotherapy or bone marrow transplant.
The study, which began in June 2000, has enrolled 104 of a planned 950
patients. IBPI (Mountain View, Calif.) ran into three problems in the trial. First, the
logistics of getting oncologists, infectious disease clinicians and microbiology labs to
work together at some of the 40 active clinical trial sites was difficult. Second, VRE
rates were lower than expected at some hospitals. Third, a